NCT03932864

Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor

A Randomized, Placebo-Controlled, Ascending Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Parameters of MGTA-145 in Healthy Subjects Administered as a Single Agent, as Well as in Combination With Plerixafor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Ensoma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in healthy volunteers as a single agent and in combination with plerixafor.

Detailed description

The study consists of up to four parts: Part A, to investigate the safety and tolerability of MGTA-145; Part B, to investigate the safety and tolerability of MGTA-145 when administered in combination with plerixafor; Part C, to investigate the safety and tolerability of two sequential days of dosing MGTA-145 in combination with plerixafor; and Part D, to investigate the safety, tolerability, and measure by apheresis, the total number of CD34+ cells mobilized after a dose of MGTA-145 administered in combination with plerixafor.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	MGTA-145	MGTA-145 will be given in various doses intravenously
BIOLOGICAL	plerixafor	240 µg/kg subcutaneously
BIOLOGICAL	Placebo	Placebo will be given in various doses intravenously

Timeline

• Start date: 2019-04-22
• Primary completion: 2020-02-25
• Completion: 2020-02-25
• First posted: 2019-05-01
• Last updated: 2024-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study